FDA 510(k)

TalarLift STS

K-Number: K170624 · 2017-08-11

Decision Date2017-08-11

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TalarLift STS is the device name listed in this FDA 510(k) record. The listed applicant is Fusion Orthopedics, LLC. It received FDA 510(k) clearance on 2017-08-11 under 510(k) number K170624. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TalarLift STS?

TalarLift STS is a medical device that received FDA 510(k) clearance on 2017-08-11. The listed applicant is Fusion Orthopedics, LLC. The 510(k) number is K170624.

When did TalarLift STS receive FDA 510(k) clearance?

TalarLift STS received FDA 510(k) clearance on 2017-08-11, under 510(k) number K170624.

Who is the listed applicant for TalarLift STS?

The FDA 510(k) record lists Fusion Orthopedics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TalarLift STS?

The FDA product code for TalarLift STS is HWC. This falls under the Cardiovascular category.

Other records listing Fusion Orthopedics, LLC as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.